Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
118 participants
INTERVENTIONAL
2009-10-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AIN457C 300 mg every 2 week dosage regimen
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each. every 2 weeks
AIN457
AIN457C 300 mg monthly dosage regimen
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg e
AIN457
Placebo
Placebo was administered in 2 s.c. injections every 2 weeks
Placebo
Interventions
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AIN457
AIN457
Placebo
Eligibility Criteria
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Inclusion Criteria
* \>2+ vitreous haze with \<2+ anterior chamber cell grade (intermediate or posterior uveitis) or \>2+ vitreous haze with \>2+ anterior chamber cell grade (panuveitis)
* presence of retinal infiltrates or vasculitis or hemorrhages
* documented \>10 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Behçet's disease.
* Requirement for either of the following immunosuppressive therapies for at least 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Behçet's disease:
* Prednisone or equivalent \>10 mg daily
* The need for at least \>1 periocular injection or \>1 intravitreal corticosteroid injection in the study eye within the past 6 months (the last injection must have not been given within 6 weeks of screening)
* Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate either as monotherapy or in combination with or without steroids. (Patients treated at any time with chlorambucil or cyclophosphamide are not eligible for the study.)
* Patients not meeting the above specified criteria for immunomodulatory therapies are eligible for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by the study investigator.
Exclusion Criteria
* Less severe (i.e. anterior) uveitis associated with Behçet's disease.
Ocular treatments
* Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to study screening.
* Treatment with any injected or implantable corticosteroid releasing device (i.e., flucinolone acetonide implant, Retisert®) in the study eye within the last 3 years.
* Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle.
Systemic conditions or treatments
* Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster virus or measles) within 2 months prior to screening.
* Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening and no prior treatment with AIN457.
* Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil).
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Arlington, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Alexandria, , Egypt
Novartis Investigative Site
Grenoble, , France
Novartis Investigative Site
Dessau, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Athens, Greece, Greece
Novartis Investigative Site
Larissa, Greece, Greece
Novartis Investigative Site
Athens, GR, Greece
Novartis Investigative Site
Heraklion - Crete, GR, Greece
Novartis Investigative Site
Ioannina, GR, Greece
Novartis Investigative Site
Larissa, GR, Greece
Novartis Investigative Site
Ioannina, , Greece
Novartis Investigative Site
Pátrai, , Greece
Novartis Investigative Site
Hong Kong, Hong Kong, Hong Kong
Novartis Investigative Site
Chennai, Tamil Nadu, India
Novartis Investigative Site
Madurai, Tamil Nadu, India
Novartis Investigative Site
Angamaly, , India
Novartis Investigative Site
New Delhi, , India
Novartis Investigative Site
Afula, , Israel
Novartis Investigative Site
Nahariya, , Israel
Novartis Investigative Site
Ramat Gan, , Israel
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Ancona, AN, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Amman, , Jordan
Novartis Investigative Site
Irbid, , Jordan
Novartis Investigative Site
Singapore, Singapore, Singapore
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Barcelona, Barcelona, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Lausanne, Switzerland, Switzerland
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Lin-Ko, , Taiwan
Novartis Investigative Site
Monastir, , Tunisia
Novartis Investigative Site
Sfax, , Tunisia
Novartis Investigative Site
Tunis, , Tunisia
Novartis Investigative Site
Ankara, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Altindag / Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Countries
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References
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Dick AD, Tugal-Tutkun I, Foster S, Zierhut M, Melissa Liew SH, Bezlyak V, Androudi S. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013 Apr;120(4):777-87. doi: 10.1016/j.ophtha.2012.09.040. Epub 2013 Jan 3.
Other Identifiers
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2009-011237-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457C2303
Identifier Type: -
Identifier Source: org_study_id
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